Off Protocol Episode 3: What’s ‘Normal’? The Hidden Burden of Heavy Menstrual Bleeding

"The data pipeline, from medical record retrieval to structured EDC output, has to be designed for regulatory scrutiny from the start. Retrofitting data quality into an operational model that wasn't built for it creates avoidable risk at exactly the wrong stage of a program."

Every cancer case in a large screening trial must be fully documented, with complete diagnostic, staging, treatment, and outcome data. Losing even a small number of cases to incomplete follow-up can undermine the statistical power the entire study was designed to achieve. The operational model has to be built around preventing that from the start.

"Clinical trials for diagnostics are increasingly time-consuming and expensive, given the large volumes of patients required. Identification and proper enrollment at accredited sites alongside novel methods of reaching patients remotely are promising developments for speeding and focusing efforts."

Last week, the FDA published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics. It is a welcome step toward faster, more practical clinical development that puts patients first, especially those for whom a clinical trial is often their best hope.